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The device is indicated for aesthetic use, including facial and neck stimulation or body skin stimulation.

The subject device, the MyoLight Microcurrent Handpieces are intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the device. There are two MyoLight Microcurrent Handpieces that connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body. The handpieces are different in dimensions but not function. The handpieces contain the electrodes that deliver microcurrent for aesthetic use. The subject device is intended to be used together with a main control unit that is equipped with a color touch screen that significantly facilitates the use of the handpieces. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about therapy type, remaining therapy time and main therapy parameters on the screen.

The provided context does not offer information about the acceptance criteria or a study proving that the device meets specific acceptance criteria in the typical format of a clinical or performance study with metrics like sensitivity, specificity, or AUC.

The document is a 510(k) summary for a medical device (MyoLight Microcurrent Handpiece) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.

However, based on the non-clinical testing section, we can infer some "acceptance criteria" through compliance with recognized standards.

Here's the breakdown of the information that can be extracted, and where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating compliance with recognized standards and similarity to predicate devices. The "reported device performance" is essentially the device's conformance to these standards and its specifications aligning with the predicate devices.

2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set in terms of patient samples. The testing described is non-clinical (bench testing, software V&V, and compliance with electrical safety and EMC standards). Therefore, there is no information on sample size or data provenance in the context of a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set using expert-established ground truth is described.

4. Adjudication method for the test set
Not applicable, as no clinical test set with adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a microcurrent handpiece, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is not an algorithm for diagnostic or prognostic purposes. It is a physical device delivering electrical stimulation, with software controls for operation.

7. The type of ground truth used
For non-clinical testing:

• Electrical Safety, EMC, and Nerve/Muscle Stimulator Standards: Compliance is based on objective measurements against defined limits in the respective IEC standards.
• Biocompatibility: Likely based on laboratory assays and tests according to ISO 10993 standards.
• Software Validation & Verification: Based on predefined software requirements specification and test protocols.
• Bench Testing: Based on objective measurements of physical and electrical parameters against design specifications.

8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device. The "training set" concept doesn't apply.

9. How the ground truth for the training set was established
Not applicable.

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The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.

The BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS: Scalp attachment, Small attachment.

The provided document is a 510(k) summary for the Beagank 4T Plus device. It does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards. It explicitly states: "No new clinical studies have been submitted as part of this Premarket Notification."

Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and a study proving those criteria are met, as such information is not present in the provided text.

However, I can extract information related to non-clinical performance and safety testing which serves as the basis for the FDA clearance in this case.

Here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

Based on the "Summary of Non-Clinical / Test Data," the device performance is demonstrated by compliance with specific safety standards. The "acceptance criteria" here are essentially passing these standards.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of submission. The tests are for device safety and electrical performance, typically conducted on a sample of the manufactured device. Details on the specific number of units tested and data provenance (country of origin, retrospective/prospective) are not provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical safety and performance evaluation, not a clinical study involving expert ground truth for interpretation. The "ground truth" is adherence to established engineering and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. The document explicitly states "No new clinical studies have been submitted." This is not an AI-assisted diagnostic device, and thus no MRMC study would be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical electrical stimulation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" is the established requirements and limits defined within the cited IEC and ISO standards.

8. The sample size for the training set:
Not applicable. There is no machine learning or AI component that would require a training set.

9. How the ground truth for the training set was established:
Not applicable.

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Intended for facial stimulation and indicated for over-the-counter cosmetic use.

The PureLift Pro Plus is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift Pro Plus probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (10).

The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D). Its outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel.

The PureLift Pro Plus unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.

Here's a breakdown of the acceptance criteria and study information for the PureLift Pro Plus, based on the provided FDA 510(k) summary:

This device is an electrical stimulator for aesthetic purposes, not an AI/ML device, so many of the requested fields (like those pertaining to AI model performance, human reader studies, or training sets) are not applicable (N/A) in this context. The acceptance criteria and performance data described relate to the safety and electrical/mechanical integrity of the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated regarding a "test set" in the context of an algorithm. The testing described (mechanical, biocompatibility, electrical, software) would typically apply to representative device units from production, not a dataset of patient cases. The document implies performance testing was done on the device itself.
   • Data Provenance: N/A for data provenance as it's not a data-driven device; the results are from laboratory testing of the physical hardware and software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable, as this is not an AI/ML diagnostic or predictive device requiring expert interpretation of results to establish ground truth. The "ground truth" here is compliance with engineering standards and safety limits, which is assessed through defined testing procedures performed by qualified engineers/technicians.
   • Qualifications of Experts: N/A.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication Method: Not applicable. The "test set" in this context refers to physical device units undergoing compliance and safety testing, not a dataset requiring human adjudication of labels or interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No. This device is a transcutaneous electrical nerve stimulator for aesthetic purposes, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: Not applicable. While the device has software/firmware control, its function is direct electrical stimulation, and it's not an algorithm providing a diagnostic or predictive output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Type of Ground Truth: The ground truth for this device's performance is adherence to established engineering standards (e.g., IEC 60601 series, ISO 10993 series), design specifications, and safety limits. This is determined through objective measurements and validated test methods, not clinical outcomes or expert consensus on a disease state.

8. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no "training set."

9. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not applicable. No training set is used.

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PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The PureLift is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). The device measures 13.4″ L x 4.8″ W x 4.3″ D. Its outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then LCD screen will be displayed, indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face. PureLift is intended to be used with a legally marketed electroconductive media. The PureLift unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.

The provided document is a 510(k) summary for the PureLift device, a transcutaneous electrical nerve stimulator for aesthetic purposes. However, it does not contain a study that directly proves the device meets specific acceptance criteria for its intended cosmetic use (facial stimulation for over-the-counter cosmetic use).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (NuFace K072260 and reference device Rejuvenique K011935) by comparing technological characteristics and presenting results of various safety and performance tests. These tests are primarily designed to ensure the device is safe and functions as intended from an engineering and biocompatibility standpoint, rather than proving its cosmetic efficacy against specific clinical acceptance criteria.

Therefore, many of the requested details, such as sample size for test sets directly assessing cosmetic efficacy, expert-established ground truth for cosmetic outcomes, MRMC studies, or standalone performance for cosmetic claims, are not present in this regulatory submission.

Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for cosmetic efficacy experiments or performance directly related to its "facial stimulation" claim. Instead, it details various engineering and safety tests and states that the device "passed or met the requirements of all testing." The table below will reflect the tests conducted and their outcomes as reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions various tests (biocompatibility, electrical safety, EMC, software V&V, and other physical/mechanical tests) but does not specify the sample size for these tests. For biocompatibility, it states "The subject device is considered tissue contacting for a duration of less than 24 hours," which refers to the classification of contact, not a sample size.

The data provenance (country of origin, retrospective/prospective) is not provided. These are typically laboratory tests performed on device units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the regulatory submission focuses on engineering, safety, and performance standards rather than clinical efficacy studies requiring expert evaluation of "ground truth" for cosmetic outcomes. The "ground truth" for the tests mentioned (e.g., biocompatibility or electrical safety) would be established by the testing standards themselves and laboratory measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant for clinical studies with subjective endpoints, which are not detailed in this 510(k) summary for engineering and safety tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done and therefore no effect size for human improvement with AI assistance is reported. This device is a direct-to-consumer electrical stimulator, not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the PureLift device is a physical electromedical device for facial stimulation, not an AI algorithm. Software verification and validation were performed for the device's control software, but this is distinct from AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the reported performance data:

• Biocompatibility: The ground truth is established by adherence to ISO 10993 standards and the results of laboratory tests (cytotoxicity, sensitization, irritation) which provide objective measures against established biological criteria.
• Electrical safety and EMC: The ground truth is established by compliance with IEC 60601 series standards, using objective measurements against specified electrical and electromagnetic limits.
• Software Verification and Validation: The ground truth is established by adherence to FDA guidance for software in medical devices, typically involving testing against software requirements and design specifications.
• Other physical/mechanical tests: The ground truth is established by meeting engineering specifications and performance limits for durability, function, etc.

For the cosmetic use indication, the document does not describe any studies that would establish a specific "ground truth" for cosmetic outcomes like facial toning or appearance improvement. The 510(k) process focuses on substantial equivalence based on technical characteristics and safety, assuming the predicate's indications are well-established.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical electrical stimulator, not a machine learning model that requires a training set for an algorithm.

9. How the ground truth for the training set was established

This question is not applicable for the reasons stated in point 8.

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